A new study looking at CTP-13, a biosimilar to infliximab ( Remicade ), showed that the biosimilar was noninferior to the innovator product.
The biosimilar CT-P13, based on the reference product infliximab, was originally approved for use in patients with active Chron’s disease in ankylosing spondylitis and also rheumatoid arthritis. Concerns over expanded indications have been expressed. Researchers, publishing the results of the randomized, double-blind, phase 3 study designed to address this concern in The Lancet, sought to evaluate the inferiority or noninferiority of CTP-13 in patients with active Chron’s disease who were naïve to biological therapy.
The study authors randomly assigned 220 patients (1:1:1:1) to receive CT-P13 then CT-P13 (n=56), CT-P13 then infliximab (n=55), infliximab then CT-P13 (n=55), and infliximab then infliximab (n=54), with switches occurring at week 30. The researchers assigned patients 5 mg/kg CT-P13 or infliximab at weeks zero, two, six, and at every eight weeks thereafter out to 54 weeks. The primary study endpoint was the proportion of patients with a decrease of 70 points or more in the Chron’s Disease Activity Index (CDAI) from baseline out to week six. They established the noninferiority margin of -20%.
According to the study results, CDAI response rates were similar at six weeks for both therapies (CT-P13, 77 of 111 [69.4%; 95% CI, 59.9 to 77.8]; infliximab, 81 [74.3%; 95% CI, 65.1 to 82.2] of 109; difference, −4·9%; 95% CI, −16.9 to 7.3), thereby establishing noninferiority. The researchers reported that 147 (67%) of patients experienced at least one treatment-emergent adverse event during the study period (36 [64%] in the CT-P13–CT-P13 group; 34 [62%] in the CT-P13–infliximab group; 37 [69%] in the infliximab–infliximab group; and 40 [73%] in the infliximab–CT-P13 group).
“This study showed non-inferiority of CT-P13 to infliximab in patients with active Crohn’s disease,” they concluded. “Biosimilar CT-P13 could be a new option for the treatment of active Crohn’s disease.”
Read more at The Lancet